Frequently Asked Questions
Working with Citruslabs
What's the difference between a consumer perception study and a clinical trial?
A perception study and a clinical study both aim to gather data to make claims, but they differ in terms of their methodology, rigor, and goals. While a perception study focuses on gaining insights into consumers' perceptions and experiences, a clinical study is designed to produce robust, scientifically-validated results that can be used to support product claims. In short, a perception study is useful for gaining insights into consumers' perceptions, while a clinical study is designed to produce robust, scientifically-validated results to support product claims. Perception studies are often less rigorous than clinical studies and may include fewer participants with less specific inclusion and exclusion criteria. They may not include comprehensive baseline questionnaires or rigorous screening processes, and instead rely on "before and after" photos and a few targeted questions to make claims. Clinical studies, on the other hand, aim to produce scientifically rigorous results, which may also be added to www.clinicaltrials.gov. They often include statistically significant sample sizes, well-defined inclusion and exclusion criteria, comprehensive baseline questionnaires, and biomarkers or skin markers to support product claims. Clinical trials are reviewed and approved by an institutional review board (IRB), and come in many shapes and forms, such as randomized-controlled trials (RCTs), single group clinical trials, or crossover studies.
Recruitment & how we determine who gets enrolled in the study
Citruslabs has a wealth of experience in the industry. We are experts in recruitment, and have a vast pool of potential study participants across various therapeutic areas. When starting a new study, we collaborate with the study sponsor (i.e. the brand) to determine the inclusion and exclusion criteria for participants. This helps ensure that the study is set up for success and that participants are only enrolled if they meet these criteria. It's important to note that sponsors cannot be involved in the enrollment process beyond setting the inclusion and exclusion criteria, as this would be considered unethical. At Citruslabs, we take ethical considerations seriously and always strive to maintain the highest standards in our recruitment processes.
What type of study would you recommend I run based on your experience?
At Citruslabs, we understand that every company, product, and study goal is unique. That's why we offer custom clinical trials that are tailored to meet your specific needs. With our expertise, we will help you determine the most suitable study design that aligns with your goals and budget, ensuring that your investment in clinical research is both effective and efficient. Whether you are looking to establish research-backed claims, improve your credibility in the medical community, or advance your brand image, we are here to support you every step of the way. As you embark on your journey to determine the best clinical study design for your needs, it's important to consider three key factors: Objectives: What are you hoping to achieve with your study? Are you looking to make research-backed claims, build credibility within the medical community, gain an edge in discussions with retailers, or establish a reputation for science-driven innovation? Understanding your goals will help you choose the best study design for your needs. Budget: There's more to clinical studies than just the gold-standard randomized controlled trial with 300+ participants. Instead of thinking, "I can't afford this, so I won't conduct a study," consider what you can achieve with your budget. Citruslabs can help you determine the most effective and efficient study design for your needs. Timing: Do you have a specific deadline for receiving study results? Understanding your timeline will help you choose the right study design, taking into account the time required to plan, conduct, and analyze your study. With these factors in mind, let's explore some of the most popular study designs: Single group clinical trial: Single gorup clinical trials focuse on your product's impact on all participants. Unlike other trial designs that include a control group or placebo group, single-group trials only involve participants receiving your product. This approach is often the starting point for many brands looking to establish positive results and build towards larger, more in-depth trials. With our expertise, we can help guide you in determining the best course of action based on the results and learnings from your single-group trial. Crossover study: A crossover trial is a highly efficient and effective type of randomized-controlled study. This design uses a single study group, but participants receive multiple interventions, or a placebo, in a predetermined order. The purpose of a crossover trial is to compare the effects of different interventions, or the intervention against a placebo. Participants act as their own controls, as each individual serves as their own comparison group for each intervention, enabling a more efficient use of resources and reducing the sample size required to detect differences between treatments. Randomized-controlled study A randomized controlled trial (RCT) is widely recognized as the highest standard of clinical research. It compares the efficacy of different interventions through the use of multiple study groups. Participants in an RCT are randomly assigned to receive either the experimental intervention (such as your product) or a control intervention, such as a placebo or no treatment. By comparing the outcomes between the groups over time, RCTs aim to eliminate bias and control for confounding variables. These rigorous study designs are essential in providing strong and reliable evidence to support the effectiveness of a product, making RCTs an indispensable tool in the world of clinical research. All of the above study types can include the following data collection methodologies: Questionnaires (validated & study-specific) Biomarkers (blood, stool, etc.) Digital biomarkers (sleep, blood pressure, weight, exercises, waist circumference, etc.) Honorable mention: Consumer perception study: A consumer perception study, while useful for marketing purposes, is distinct from a clinical trial. Unlike clinical trials, consumer perception studies primarily rely on self-reported surveys that address specific product-related concerns. These studies often lack a comprehensive baseline questionnaire, focusing instead on collecting data to support product claims. However, they can include before and after photos to help illustrate the impact of the product. It's important to note that consumer perception studies are not considered scientific and do not provide the same level of evidence as a clinical trial. Perception studies are a common tool used in the cosmetic industry to create claims.
How long should our study period should be?
Citruslabs offers custom clinical trials and as such, we don’t provide a one-size-fits-all approach to study length. The length of a clinical trial depends on several factors, including the type and complexity of the intervention being tested, the size of the patient population, and the desired level of statistical significance. The length of a clinical trial is determined based on the specific objectives and design of the study, and can range from a few months to several years. Ultimately, the duration of a clinical trial should be long enough to produce meaningful and statistically significant results. A typical study period for consumer products is between 2-12 weeks. While some products have intervention periods of 3-12 months. Rarely we see study periods that are longer than 12 months.
What is your range of capabilities?
At Citruslabs, we pride ourselves in conducting a wide range of customized clinical studies. Here is what we can do: Consumer perception Single group clinical trial Crossover study Randomized-controlled trial For cosemtics: Citruslabs offers a comprehensive approach to skin analysis through the use of questionnaire-based studies and instrument evaluations. Our in-depth studies include pre- and post-examination comparisons, utilizing state-of-the-art tools such as the OpticElite skin analyzer, corneometer, cutometer, and tewameter. To ensure the most accurate results, we also provide expert skin grading performed by one of our highly trained and experienced in-house dermatologists. For supplements/superfoods: At Citruslabs, we gather data from a wide range of sources to provide comprehensive insights into supplement efficacy. This includes the use of validated and study-specific questionnaires, as well as the collection of both traditional biomarkers such as blood work and stool samples, and digital biomarkers such as sleep patterns, blood pressure, and weight. Depending on the specific supplement under examination, we may also incorporate skin assessments and pre- and post-examination comparisons to further enhance our data analysis.
What happens if my study doesn’t produce good results?
When a study fails to produce favorable results, it often indicates that the intervention being tested is not effective. For brands, this means going back to the drawing board and re-evaluating the product formulation. The design of the study also plays a crucial role in achieving successful outcomes. For example, conducting a randomized-controlled trial with a placebo comparison is more likely to yield statistically insignificant results, compared to a single-group clinical trial. It's essential to consider the study design carefully to optimize the chances of obtaining meaningful and actionable results.
Does the study get published?
Not all clinical trials are published, and there is no standard for which trials must be published. The decision to publish clinical trial results depends on several factors, including the significance of the results, the quality of the study, and the preferences of the study sponsors and authors. Generally, if you have a supplement that uses no innovative ingredients, or ingredients are are well-researched already, it’s fairly unlikely to get published, because it’s not a scientific breakthrough. But, if you have an innovative supplement, with new ingredients then you have higher chances getting published. Generally, we encourage sponsors that work with us to publish their study on www.clinicaltrials.gov. You don’t have to publish results on there, but only that a study was conducted.
If we just use questionnaires, is it a legitimate clinical study?
Clinical trials that rely solely on questionnaires as a data collection method are considered valid and can provide insightful information about the real-world impact, safety, and effectiveness of interventions, as well as patients' experiences and perspectives. Questionnaire-based trials are particularly useful in capturing subjective outcomes, such as mental health, focus, attention, memory, pain, fatigue, and mood, which are difficult to measure objectively. For instance, studies measuring period pain can greatly benefit from the use of questionnaires. However, to enhance the clinical trial, the use of objective data collection methods, such as blood tests and digital markers (such as weight, sleep, blood pressure, etc.), can be incorporated to add more robustness to the findings. This combination of subjective and objective data collection methods can provide a comprehensive understanding of the impact of the intervention on patients' daily lives.
Is a single-group study inferior to a randomized controlled trial?
Single group studies and randomized-controlled trials (RCTs) both have strengths and weaknesses, and the superiority of one over the other depends on the specific research question and the context of the study. Single group studies involve observing a group of patients before and after an intervention, without a comparison group. These studies are often simpler and less expensive to conduct than RCTs, and can be useful for generating hypotheses and identifying potential areas for further research. On the other hand, RCTs are considered the gold standard for evaluating the efficacy and safety of an intervention. RCTs involve randomly allocating patients to receive either the intervention or a control treatment, and comparing the outcomes between the two groups. RCTs are less susceptible to bias than single group studies and can provide stronger evidence of causality. However, RCTs can be more complex, expensive, and time-consuming to conduct, and may not always be feasible or ethical, depending on the research question and the population being studied. Both, single group studies and RCTs have their place in clinical research, and the choice between the two depends on the specific research question and the available resources. A single group study may provide useful preliminary evidence, while an RCT is necessary to establish causality and to provide stronger evidence for decision-making in clinical practice. For most consumer brands, single group studies are enough to substantiate their claims and the efficacy of their product.
How many people do I need to enroll in my study?
The number of participants required for a clinical study depends on several factors, including the research question, the intervention being studied, the size of the population being studied, the desired level of precision of the results, and the expected effect size. In general, a larger sample size increases the power of the study, which is the ability to detect a true effect if one exists. The sample size also affects the precision of the results, as a larger sample size provides a more precise estimate of the true effect. The sample size can be calculated using statistical methods, taking into account the desired level of power and the expected effect size. The sample size calculation should also consider the potential for dropout or loss to follow-up, which can reduce the effective sample size and affect the power of the study. In practice, the number of participants required for a clinical study can range from a few dozen to several thousand, depending on the factors mentioned above. It is important to note that enrolling a larger number of participants is not always necessary or feasible, and that the sample size should be carefully considered and justified based on the research question and the available resources.
Do I have join a waiting list before we can start working on our study?
At Citruslabs, we prioritize efficiency and speed in our clinical studies. By utilizing cutting-edge technology, we are able to conduct multiple studies simultaneously, without the hindrance of a waiting list. As soon as you choose to partner with us, we can commence work on your study immediately, providing you with swift results. With our innovative approach, you can rest assured that your clinical study will be conducted smoothly and efficiently.